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Related Experiment Videos

Sertindole for schizophrenia.

R Lewis1, A Bagnall, M Leitner

  • 1NHS Centre for Reviews and Dissemination, University of York, York, North Yorkshire, UK, YO10 5DD. rl14@york.ac.uk

The Cochrane Database of Systematic Reviews
|May 5, 2000
PubMed
Summary
This summary is machine-generated.

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Sertindole shows antipsychotic effects but carries risks of cardiac issues and weight gain. Due to cardiac concerns, sertindole should be avoided until its benefits clearly outweigh its risks.

Area of Science:

  • Psychiatry and Pharmacology
  • Clinical Trials and Evidence Synthesis

Background:

  • Sertindole, an atypical antipsychotic, was developed to reduce extrapyramidal side effects compared to typical antipsychotics.
  • Concerns regarding cardiac arrhythmia and sudden cardiac death led to the voluntary suspension of sertindole availability in December 1998.
  • The drug's market status was pending discussions with regulatory authorities concerning its cardiac safety profile.

Purpose of the Study:

  • To evaluate the efficacy and safety of sertindole in comparison to placebo, typical, and other atypical antipsychotic medications for schizophrenia and related psychoses.
  • To synthesize evidence from randomized controlled trials to inform clinical practice and regulatory decisions regarding sertindole use.

Main Methods:

  • Comprehensive electronic literature searches were conducted across multiple databases (e.g., MEDLINE, EMBASE, PsycLIT) from inception to 1999.

Related Experiment Videos

  • Inclusion criteria focused on randomized controlled trials comparing sertindole with placebo or other antipsychotics, with independent assessment of study quality and data extraction.
  • Statistical analyses included risk ratios (RR), confidence intervals (CI), number needed to treat (NNT), and weighted mean differences (WMD) to assess treatment effects and heterogeneity.

    • Main Results:

    • Two included randomized controlled trials indicated sertindole was more antipsychotic than placebo and better tolerated than haloperidol, with fewer movement disorders.
    • However, sertindole use was associated with increased weight gain, rhinitis, and potential male sexual dysfunction compared to haloperidol.
    • Significant cardiac issues, specifically QTc interval prolongation (≥500msec), were observed in randomized trials, indicating a notable risk (NNH=13).

    Conclusions:

    • The observed cardiac risks, even in limited studies, suggest that sertindole should be avoided if possible in its current state.
    • Reintroduction of sertindole would necessitate robust, gold-standard evidence demonstrating that its clinical benefits substantially exceed its identified risks.
    • Further research and regulatory scrutiny are required to ascertain the appropriate role, if any, for sertindole in the management of schizophrenia.